Description and Brand Names

US Brand Name

Descriptions

Lacosamide injection is used to control partial seizures (convulsions) in the treatment of epilepsy. It acts on the central nervous system (CNS) to reduce the number and severity of seizures.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of lacosamide injection in children younger than 17 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lacosamide injection in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require caution in patients receiving lacosamide injection.

Pregnancy

Information about this lacosamide-intravenous-route

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol

Amitriptyline

Amlodipine

Atazanavir

Atenolol

Betaxolol

Bisoprolol

Carteolol

Carvedilol

Celiprolol

Chlordiazepoxide

Cinnarizine

Clevidipine

Diltiazem

Dolasetron

Eslicarbazepine Acetate

Esmolol

Felodipine

Isradipine

Labetalol

Levobunolol

Lopinavir

Metipranolol

Metoprolol

Nadolol

Nebivolol

Nicardipine

Nifedipine

Nimodipine

Nisoldipine

Orlistat

Oxprenolol

Penbutolol

Pindolol

Practolol

Propranolol

Quinine

Ritonavir

Saquinavir

Sotalol

Timolol

Verapamil

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Brugada syndrome (genetic disease) or

Depression, history of or

Drug abuse or dependence, history of or

Heart attack or

Heart block or

Heart disease (eg, heart failure, myocardial ischemia) or

Heart failure or

Heart rhythm problems (eg, prolonged PR interval) or

Mental illness, history of or

Sick sinus syndrome (type of abnormal heart rhythm), without pacemaker—Use with caution. May make these conditions worse.

Diabetic neuropathy or

Heart or blood vessel disease—May increase risk for more serious side effects.

Kidney disease, severe or

Liver disease, mild to moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Liver disease, severe—Should not be used in patients with this condition.

Proper Use

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 15 to 60 minutes.

Your doctor may give you a few doses of this medicine until your condition improves, and then you may be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Ask your doctor if you have any questions.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

It is important to tell your doctor if you become pregnant or planning to become pregnant. Your doctor may want you to join the North American Antiepileptic Drug Pregnancy Registry. This registry is used by pregnant patients who are using this medicine.

If you develop any unusual or strange thoughts and behavior while receiving lacosamide injection, be sure to discuss it with your doctor. Some changes that have occurred in people receiving this medicine are like those seen in people who drink too much alcohol. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

This medicine may cause blurred vision, double vision, clumsiness, unsteadiness, dizziness, drowsiness, sleepiness, or trouble with thinking. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well. If these side effects are especially bothersome, check with your doctor.

This medicine can cause changes in heart rhythms, such as a condition called PR prolongation. It may change the way your heart beats and cause lightheadedness, fainting, or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, slow, or irregular heartbeats.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Blurred vision

double vision

headache

nausea

seeing double

vomiting

Less common

Diarrhea

feeling of constant movement of self or surroundings

lack or loss of strength

sensation of spinning

uncontrolled eye movements

Incidence not known

Acid or sour stomach

belching

difficulty having a bowel movement (stool)

dry mouth

heartburn

indigestion

muscle spasms

stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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